NCT04520139 · University of California, Irvine
Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
What this study is about
This is a phase I, gradually increasing doses and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and how well patients handle the treatment of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT).
View original scientific description
This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).
Interventions
DRUG
N-Acetyl-Cysteine
Given PO
OTHER
Placebo
Given PO
Primary outcome measures
Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy
Time frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first.
Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.
Recommended Phase 2 Dose for NAC administered with PBT
Time frame: From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first.
Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)
- Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Eastern Cooperative Oncology Group (ECOG) ≤2
- Life expectancy \> 1 year
- Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
- Prescribed a minimum of six cycles of platinum-based chemotherapy
- Adequate organ function as defined below:
- Hemoglobin \> 9 g/dL
- Leukocytes \>1,500/mcl
- Absolute Neutrophil Count \> 1,000/mcL
- Platelets \> 125,00/mcL
- total bilirubin Within normal institutional limits
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 x institutional upper limit of normal
- Serum creatinine \< 1.5 mg/dL.
Exclusion criteria
- Prior history of any cancer (other than non-melanoma skin cancer)
- Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
- Prior severe head injury
- Has a history of dementia or other neurodegenerative disorders
- Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
- Presence of known brain metastases
- Has an active infection requiring treatment
- Known immunosuppressive disease
- Has active systemic autoimmune diseases such as lupus
- Receipt of systemic immunosuppressive therapy
- Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
- Pregnant of breastfeeding.
Where
- Orange, California
Collaborators
Jarrow Formulas Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 17, 2026 · Source of record for eligibility and locations